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Noteworthy FDA Developments: Menu Labeling and Tobacco Products Requirements Delayed; Gottlieb’s Nomination Advances

Posted: May 2, 2017

Menu Labeling Rule Delayed

Just a few days before the U.S. Food and Drug Administration’s (FDA or the Agency) Menu Labeling Rule (the Rule) was set to go live, the Agency released an interim final rule that delays the Rule until May 7, 2018.

As we have discussed previously (here, here, and here), the Menu Labeling Rule requires restaurants and “similar retail food establishments” (e.g., convenience stores and grocery stores) that are part of a chain of 20 or more locations and that sell similar menu items to post on menus and menu boards: (1) calorie information; (2) a statement on suggested daily caloric intake; and (3) a statement that written nutrition information is available upon request (and provide such information upon request).

Also as discussed in a previous piece, the National Association of Convenience Stores (NACS) and the National Grocers Association (NGA) last month filed a Citizen Petition with the Agency, which requests a stay and reconsideration of FDA’s Menu Labeling Rule. NGA and NACS argue, among other things, that:

  • Their members cannot comply with the current Rule;
  • FDA underestimates compliance costs, especially for retailers; and
  • The Rule violates the First Amendment.

In deciding to delay the Rule, the Agency seems to have been persuaded by the Trump administration’s calls to reduce regulations that burden businesses (see, e.g., here and here) and by the NACS/NGA Citizen Petition. In explaining its decision, FDA indicated that it is taking the action both “to enable us to consider how we might further reduce the regulatory burden or increase flexibility while continuing to achieve our regulatory objectives, in keeping with the [Trump] Administration’s policies” and “in response to the diverse and complex set of stakeholders affected by the rule and continued, numerous, and fundamental questions they raise regarding the final rule and its implementation.” While the interim final rule merely delays the Menu Labeling Rule’s compliance date, one has to wonder whether the Rule’s future could now be in jeopardy, altogether.

Tobacco Products Deeming Rule Compliance Dates Reportedly Extended

Beyond delaying its Menu Labeling Rule, the Agency is reportedly planning to also delay portions of its tobacco products Deeming Rule. Cigar Rights of America (CRA) announced in a press release on May 1, 2017 that the U.S. Department of Justice (DOJ) recently advised the United States District Court for the District of Columbia that FDA will extend and defer enforcement of all future compliance dates under the Agency’s Deeming Rule for three months. The Deeming Rule subjects e-cigarettes, cigars, hookah tobacco, and pipe tobacco to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Per CRA, FDA will soon issue guidance regarding the Agency’s purported Deeming Rule compliance date plans.

By way of background, CRA, The Cigar Association of America (CAA), and the International Premium Cigar & Pipe Retailers Association (IPCPR) filed a motion for summary judgement in the organizations’ joint lawsuit against FDA in February 2017. CAA, CRA, and ICPCR have alleged that FDA’s Deeming Rule: is arbitrary, capricious, an abuse of discretion, and not in accordance with law; is in excess of statutory jurisdiction, authority, or limitations, or short of statutory right; and violates the Regulatory Flexibility Act. Also in February 2017, Arizona, Louisiana, Michigan, and Texas filed an amicus curiae brief opposing the Agency’s regulation of premium cigars as part of CAA’s, CRA’s, and IPCPR’s suit against the Agency. The states make two main points:

  1. FDA failed to provide an adequate cost-benefit analysis determining that the benefits of deeming premium cigars to be regulated tobacco products outweigh the undeniably severe costs, particularly to thousands of small businesses; and
  2. FDA failed to adequately address the way in which deeming cigars will undermine the public health programs funded by state excise taxes on non-cigarette tobacco products.

The United States District Court for the District of Columbia had scheduled a July 28, 2017 hearing in the case, although it remains to be seen how, if at all, that date would change as a result of FDA’s purported delay of future Deeming Rule compliance dates.

Gottlieb’s Nomination Advances

Finally, the Senate Health, Education, Labor and Pensions (HELP) Committee recently voted, 14 to 9, to approve Dr. Scott Gottlieb to be the next FDA Commissioner (more on Gottlieb here). The committee’s 12 republicans voted for Gottlieb’s nomination, with HELP Committee Chairman Lamar Alexander (R-Tenn.) noting that Gottlieb is “the right person to lead the Food and Drug Administration in its vital mission and move the agency forward.” In contrast, Sen. Patty Murray (D-Wash.), HELP Committee Ranking Member, voted no in light of her assessment that Gottlieb’s “entanglements with the industries he will be charged with overseeing are unprecedented.” Gottlieb’s nomination now moves to the full Senate for a vote.